The NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials (PAR-24-066) is a funding opportunity provided by the National Eye Institute (NEI) under the National Institutes of Health (NIH). This grant aims to support small business concerns (SBCs) in conducting early-stage clinical trials with greater than minimal risk, typically focusing on Phase I or Phase II studies. The purpose of this funding is to foster the development of new interventions for screening, diagnosing, preventing, or treating vision-related disorders. Given the nature of these trials, which involve greater than minimal risk, the cooperative agreement format is used to ensure close oversight, safety monitoring, and collaboration between the NIH and the funded entity.

Applicants must be small businesses as defined by the eligibility requirements, which exclude foreign organizations and non-domestic components of U.S. entities, though certain foreign components may be considered as per the NIH Grants Policy Statement. The opportunity does not require cost-sharing or matching contributions from applicants. Although there is no specified award ceiling or floor, the funding is structured as a discretionary grant, allowing for flexibility in award amounts based on the scope and potential impact of the proposed clinical trial.

The primary objective is to encourage innovative research that can advance the understanding and treatment of eye diseases and disorders. Applicants are expected to have a well-developed clinical trial protocol that addresses the specific risks associated with early-stage human trials. The interventions proposed should be scientifically sound and have the potential to significantly improve clinical outcomes for individuals with vision impairments or disorders. Given the nature of these studies, which involve human subjects, applicants are strongly advised to engage with NEI program staff before submission to discuss the project’s design, safety monitoring plans, and the suitability of this funding mechanism.

Submissions are open until January 7, 2027, providing a long window for potential applicants to prepare their proposals. The cooperative agreement format indicates a partnership with the NIH, wherein the agency will provide substantial programmatic involvement throughout the project. This includes input on study design, execution, and data monitoring, ensuring that the trials meet safety and ethical standards while addressing significant research questions in vision health.

For those interested in applying, it is important to demonstrate not only technical feasibility but also a clear regulatory strategy and a plan for subsequent clinical development. The funding supports projects that are past the basic research stage but are not yet ready for large-scale clinical trials. This includes trials that aim to establish proof of concept or to gather initial data on efficacy and safety that could lead to later-phase studies.

Applicants can find further details, including submission guidelines, by visiting the NIH grants website linked in the announcement. Queries regarding the application process can be directed to the NIH grants information email provided.